FDA Adverse Event Malfunction Summary report: N

LINET

MDR report key: 16627159 · Received March 28, 2023

Report

Report Number
16627159
Event Type
Malfunction
Date Received
March 28, 2023
Date of Event
March 15, 2023
Report Date
March 21, 2023
Manufacturer
LINET AMERICAS
Product Code
FNL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A NURSE WAS REMOVING SEIZURE PADS FROM A BED SIDE RAIL AND THE CLEAR PLASTIC PORTION OF THE PAD BROKE. SHE STATED WAS USING PROPER TECHNIQUE TO REMOVE THE PAD AND THE PLASTIC SUDDENLY BROKE WHEN SHE PULLED ON IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
13863 LINET BED, AC-POWERED, ADJUSTABLE, HOSPITAL FNL LINET AMERICAS MCHDLF

Patients

Seq Age Sex Outcome Treatment
1 Unknown